Regulatory Affairs Manager (BBBH35844) Northern Beaches, Australia
Benefits
Work with a global company
A seat on the leadership team
Work across a variety of products across Over The Counter, devices and pharmaceuticals
About the company
A long standing family owned pharmaceutical company with a global reach. They always striving to take on new products and therapies through their active partnership programme resulting in a healthy pipeline to invest in.
About the opportunity
Lead the Regulatory and Quality functions in this hands on role to ensure that product registrations and submissions comply with current best practice standards. As a member of the leadership team you will be instrumental in setting up strategic plans and providing oversight for established and new products.
Duties
- Develop and manage regulatory strategies for company products
- Direct and manage product registrations and submissions
- Liaise with regulatory bodies
- Performing the tasks of the QMR (Quality Management Representative)
- Liaising with ANZ regulators as required in regards to Quality
- Supporting regular internal and external quality audits
- Supervise and manage the activities of personnel that report to position
- Responsible for the professional development for direct reports
Skills and Experience
- Tertiary qualification in a relevant scientific discipline or equivalent
- Proven regulatory experience across pharmaceutical OTC and devices
- A full strategic understanding of the drug development principles and processes
- Experience of working on major regulatory applications in ANZ
- Experience in regulatory management systems where Veeva RIMS or TrackWise would be advantageous
- Line management experience or ability to demonstrate leadership qualities
Culture
Collaborative, supportive and progressive environment.
How to Apply
Click apply or contact Davina Ocansey, Recruitment Consultant on +61 2 8877 8712 for a confidential discussion.